Table 3.
Summary of adverse events (AE) within 14 days after dose administration
| AE type | MK-7622 45 mg (N = 119) | Placebo (N = 120) | Estimated difference (95% CI)∗ |
|---|---|---|---|
| AE Summary | |||
| Any AE | 83 (69.7) | 71 (59.2) | 10.6 (−1.6 to 22.5) |
| Drug-related AE | 34 (28.6) | 24 (20.0) | 8.6 (−2.3 to 19.4) |
| Serious AE | 9 (7.6) | 4 (3.3) | 4.2 (−1.7 to 10.9) |
| Serious drug-related† AE | 1 (0.8) | 0 (0.0) | 0.8 (−2.3 to 4.6) |
| Death | 0 (0.0) | 0 (0.0) | 0.0 (−3.1 to 3.1) |
| Discontinued due to AE | 19 (16.0) | 7 (5.8) | 10.1 (2.3 to 18.5) |
| Discontinued due to drug-related† AE | 10 (8.4) | 6 (5.0) | 3.4 (−3.2 to 10.4) |
| Discontinued due to serious AE | 6 (5.0) | 0 (0.0) | 5.0 (1.8 to 10.6) |
| Discontinued due to serious drug-related† AE | 1 (0.8) | 0 (0.0) | 0.8 (−2.3 to 4.6) |
| Cholinergically related AEs | |||
| Any cholinergically related AE‡ | 25 (21.0) | 10 (8.3) | 12.7 (3.8 to 21.9)‡ |
| Diarrhea | 18 (15.1) | 7 (5.8) | 9.3 (1.6 to 17.6) |
| Hyperhidrosis | 5 (4.2) | 0 (0.0) | 4.2 (1.0 to 9.5) |
| Vomiting | 3 (2.5) | 1 (0.8) | 1.7 (−2.3 to 6.4) |
| Nausea | 2 (1.7) | 2 (1.7) | 0.0 (−4.4 to 4.5) |
| Salivary hypersecretion | 1 (0.8) | 0 (0.0) | 0.8 (−2.3 to 4.6) |
| Bradycardia | 1 (0.8) | 0 (0.0) | 0.8 (−2.3 to 4.6) |
| Abdominal pain | 1 (0.8) | 2 (1.7) | −0.8 (−5.1 to 3.1) |
| Salivary gland pain | 0 (0.0) | 0 (0.0) | 0.0 (−3.1 to 3.1) |
| Atrioventricular block | 0 (0.0) | 0 (0.0) | 0.0 (−3.1 to 3.1) |
| Common AEs ≥5% in either group | |||
| Diarrhea | 18 (15.1) | 7 (5.8) | 9.3 (1.6 to 17.6) |
| Headache | 11 (9.2) | 6 (5.0) | 4.2 (−2.5 to 11.5) |
| Rhinorrhea | 7 (5.9) | 1 (0.8) | 5.0 (0.6 to 10.9) |
| Urinary incontinence | 6 (5.0) | 0 (0.0) | 5.0 (1.8 to 10.6) |
| Weight decreased | 6 (5.0) | 2 (1.7) | 3.4 (−1.5 to 9.1) |
| Urinary tract infection | 6 (5.0) | 7 (5.8) | −0.8 (−7.2 to 5.5) |
| Fall | 2 (1.7) | 6 (5.0) | −3.3 (−9.0 to 1.6) |
Abbreviation: CI, confidence interval.
NOTE. Data are represented as number (%) of participants.
∗
Difference versus placebo based on the Miettinen and Nurminen method.
†
Determination made by investigator while blinded.
‡
P value = .006 versus placebo based on the Miettinen and Nurminen method; statistical testing (P value) was only prespecified for the “any cholinergically related AE” category.